Minimix



United States Patent a corporation of Delaware [54] MlNlMlX 8 Claims, 4 Drawing Figs.

[52 U.S.Cl. 128/218, 7 128/218 511 lnt.Cl A6lj 1/00, A6lm5/l8 [S0] Fieldol'Search l28/2l8C,

218M, 2l5. 220, 218, 272, 221, 214; 206/43; 222/81; l4l/2l,22

[56] References Cited UNITED STATES PATENTS 3,336,924 8/1967 Sarnoff et al. 206/43 128/272 3,397,694 8/1968 Ogle Primary ExaminerL. W. Trapp Assistant ExaminerJ. B. Mitchell AttorneyFinkelstein & Mueth ABSTRACT: A two-compartment device for the administration of medicaments which is particularly adapted for containing a dry or lyophilized product and the diluent therefor in separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed. The device includes a hypodermic syringe barrel having an open end and a closed end, a boss extending from said closed end, a needle affixed to said boss, means for enclosing medicament associated with said barrel, a tubular needle cover enclosing said needle, one end of said needle cover sealing on said boss, the other end of said needle cover containing an opening therein coaxial with said needle, received in said opening a medicament vial, said medicament vial having an open end and a closed end, received in the open end'of said medicament vial a resilient imperforate stopper, said stopper being adapted to be punctured by the open end of said needle to permit the transfer of the contents of said medicament vial to the medicament container associated with said barrel and vice versa.

Patented Nov. 24, 1970 3,542,023

.Fza; I 1. 515;:

IN'VENTOR. 605667 44 0645 MINIMIX BACKGROUND OF THE INVENTION The field of the present invention pertains to devices for the packaging and administration of medicaments.

Heretofore various devices have been proposed for the prepackaging of dry w'et medicaments. However, all of these structures have been characterized by various drawbacks including the need for complicated structures which are difficult to form and expensive to manufacture, the need for a plurality of parts, complexity of operation, lack of adaptability to lyophilization operations, and potential for failure in operation. An example of such a device is shown in US. Pat. No. 2,772,677. This device isobviously difficult to manufacture and it is not possible to lyophilize in either chamber thereof. Further, the device does not permit repeated transfers between chambers, a practice generally necessary to assure complete mixing and dissolutionof dry medicaments. Thus, there has been a long felt need for a two-compartment medicament device in'vvhich one of the medicament chambers can be used for lyophilization, and then both chambers effectively sealed against contact with the exterior until such time as it is desired to administer the medicine whereupon the contents of the two medicament chambers can be thoroughly intermixed and administration accomplished without the need for any auxiliary device. The present invention, it is believed, represents a significant breakthrough in this art by providing a two-compartment medicament device which is quite simple in construction and foolproof in operation.

SUMMARY OF THE INVENTION The present invention comprises a tubular needle cover and medicament vial assembly for enclosing the needle extending vial having an open end and a closed end, received in theopen end of said medicament vial a resilient imperforate stopper,

said stopper being adapted to be punctured by the open end of said needle when said container is moved over said tubular needle cover to permit the transfer of the contents of said I medicament vial to the medicament container associated with said barrel and vice versa.

The present invention also comprises a novel two-compartment device for the administration of medicaments which is particularly adapted for containing a dry or lyophiliaed product and the diluent therefor in separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed which comprises a hypodermic syringe barrel having an open end and a closed end, a boss extending from said closed end, a needle affixed to said boss, means for enclosing medicament associated with said barrel, a tubular needle cover enclosing said needle, one end'of said needle cover sealing on said' boss, the other 'end of said needle cover containing an opening therein coaxial with said needle, received'in said opening a medicament vial, said medicament vial having an open 'end and a closed end, received in the open end of said medicament vial a resilient imperforate stopper, said stopper being adapted to be punctured by'the open end of said needle to permit the transfer of the contents of said medicament vial to the medicament enclosing mean'sassociated with said barrel and vice vermedicament vial assembly useful with any type of hypodermic syringe.

It is an object of the present invention to provide a novel two-compartment medicament device.

More particularly it is an object of the present invention to provide a two-compartment medicament device uniquely adapted for dry-wet systems involving lyophilization.

DESCRIPTION OF PREFERRED EMBODIMENTS Turning to the drawings:

FIG. 1 shows a partial sectional view of an embodiment of the needle cover of the present invention;

FIG. 2 shows a partial sectional view of an embodiment of the present invention wherein the syringe barrel and plunger are of the conventional type and adapted to provide one of the medicament compartments, while the second medicament compartment is part of the needle cover shown in FIG. 1;

FIG. 3 shows a sectional view of one embodiment of the present invention wherein both of the medicament compartments are threadably connected, one to the syringe barrel and the other to the needle cover;

FIG. 4 is a sectional view of another embodiment of the needle cover of the invention. This embodiment is similar to that of FIG. 1 except that' the outer surrounding barrel portions on the needle cover has been eliminated.

In the embodiment of F IGS. 1 and 2 the syringe is of a conventional construction and comprises barrel 10 provided with a longitudinally reciprocatable plunger 12. The contents of the barrel 10 may be forced through the needle 14 by simply depressing the plunger 12 within the barrel It). In this embodiment the needle cover 16 is provided with an external barrel l8 and a thrust portion 20. Received in the open end of the It is a major object to provide a novel needle cover and v needle cover is vial 22 provided with an imperforate stopper 24. The vial is held in place by annular projection 25 which forms a press fit with the external walls of the vial. The vial is forcibly slidable-pas't projection 25 so that when it is desired to operate this device, the vial 22 is simply forced over the end of the needle 14 causing the puncturing of the stopper 24, in this way, the medicament can be transferred from the syringe bar rel to the vial and vice versa.

FIG. 3 shows a syringe barrel 26 having an inner thrust portion 28. The barrel 26 has a closed end wall portion 30. Extending through this end wall is needle 32. Received in the open end of barrel 26 is medicament vial 34 having a stopper 36 in the closed end thereof. Stopper 36 is provided with a projection 38 having external male threads 40 thereon. The threads-40 are adapted to be made up with the threads 42 on the interior of thrust portion 28. During normal storage, the threads are not fully made up. In this way, the needle does not contact the interior'contents of the vial. However, when it is desired to operate the device, the needle is communicated with the contents of the vial by simply making up the threads 'so that the stopper 36 is punctured by the needle. The boss 44 on barrel 26 forms a seal with the needle cover 46 which comprises an interior thrustportion 48 and an exterior barrel portion 50. Received in the open end of the needle cover-is vial 52 provided with a stopper 54 having a projection 56 on which is carried the threads 58 for being made up with the threads 60 on the thrust portion 48. The operation of this vial is essentially the same as the vial provided at the open end of the syringe barrel.

As will be apparent to those skilled in the art, the needle cover of FIG. 1 may be employed with the syringe structure of FIG. 3.

Similarly, the needle cover of FIG. 3 may be employed with the syringe barrel of FIG. 2.

The device of FIG. 4 is generally similar to that of FIG. 1 except that the exterior barrels on the needle cover have been eliminated. Likewise, the needle cover 64 is provided with wings 66 for gripping the lower end of the device. The mode of operation of the device is otherwise essentially the same as the device of FIG. 1.

While not essential, the needle cover assemblies of this invention when not joined to a syringe, are provided with closures 68 and 70. Naturally, these closures are removed prior to final assembly.

In operation, normally the one medicament vial contains a dry or liquid material, and the other medicament vial contains a liquid material. The preassembled position for the device is such that neither of the vial stoppers are punctured by the needle in the case of the device of FIG. 3. In the case of the device of HG. 2, the single vial stopper is not punctured in the preassembled position. When it is desired to operate the device, the vial stoppers or stopper are punctured by either forcing the vial stopper over the needle or by the making up of the threads on the vial stopper with those on the needle cover or thrust portion. in any event, the needle is utilized to communicate the contents of the two medicament containers. in this way, it is possible to mix two different fluids immediately prior to administration. Alternatively, the device may be utilized to mix a dry and wet material immediately prior to administration, such as the mixing ofa dry lyophilized material with a diluent.

in the present invention, once the needle is communicated with the contents of the two medicament compartments, it is a simple matter to repeatedly transfer fluid from one compartment to the other. In this way, the medicament is thoroughly mixed and any dry material is completely dissolved. This is a major advance over prior art devices in which the devices were incapable for repeated transfers of fluid from compartment to compartment.

The vials used in this invention are adapted for use in the lyophilizer since the flat closed end is an excellent heat transfer surface. This eliminates a major problem of the prior art where the two-compartment medicament packages were not compatible with lyophilizers.

As will be immediately apparent to those skilled in the art, the present invention represents a significant advance in the field of two-compartment medicament administration devices. The device is simple in construction and easy to operate. In addition, the medicament cannot come in contact during storage with any metal or other materials which could cause the deterioration of any medicament packaged in the device. It has been found that medicaments may be stored over prolonged periods of time in the device of the present invention without any deterioration of the medicament taking place.

Those skilled in the art will-also recognize that the novel needle covers disclosed in this patent may be used with any of the syringes disclosed in applicants copending applications Ser. Nos. 474,413 now U.S. Pat. No. 3,378,008, issued Apr. 16, 1968, and 551,291 now U.S. Pat. No. 3,376,866, issued Apr. 9, i968, the disclosures of which are expressly incorporated herein by reference.

Having fully described the invention it is intended that it be limited only by the lawful scope of the appended claims.

I claim:

1. A tubular needle cover and medicament vial assembly adapted to enclose the needle extending from a syringe barrel, said cover having an opening at one end which is adapted to form a seal with said syringe, the other end of said needle cover having anopening therein coaxial with said needle, received in said opening a medicament vial, said medicament vial having an open end and a closed end, received in the open end of the medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper being adapted to be punctured by said needle when said vial is moved relative to said tubular needle cover to permit the transfer by reciprocation of said stopper within said vial of the contents of said medicament vial to the medicament container associated with said barrel and vice versa, said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured.

2. A tubular needle cover and medicament vial assembly adapted to enclose the needle extending from the boss of a syringe barrel, said cover having one end which seals on said boss, the other end of said needle cover having an opening therein coaxial with said needle, received in said opening a medicament vial, said medicament vial having an open end and a closed end, received in the open end of the medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper having thereon a threaded projection, said opening in said needle cover being provided with complementary threads adapted to be made up with the threads on said projection to form an interlock between said needle cover and said stopper, said stopper being adapted to be punctured by said needle when said vial is moved over said tubular cover to permit the transfer, by reciprocation of said stopper within said vial, of the contents of said medicament vial to the medicament container associated with said barrel and vice versa, said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured.

3. A tubular needle cover and medicament vial assembly adapted to enclose the needle extending from the boss of a syringe barrel, said cover having one end which seals on said boss, the other end of said needle cover having an opening therein coaxial with said needle, connected to said cover at that end which seals on said boss, an exterior barrel surrounding said needle cover and substantially coextensive therewith in length forming an annular space between said needle cover and said barrel, received in said opening of said needle cover a medicament vial, said medicament vial having an open end and a closed end, received in the open end of the medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper being adapted to be punctured by said needle when said vial is moved into said annular space over said tubular cover to permit the transfer, by reciprocation of said stopper within said vial, of the contents of said medicament vial to the medicament container associated with said barrel and vice versa, said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured.

4. A tubular needle cover and medicament vial assembly adapted to enclose the needle extending from the boss of a syringe barrel, said cover having one end which seals on said boss, the other end of said needle cover having an opening therein coaxial with said needle connected to said cover at that end which seals on said boss, an exterior barrel surrounding said needle cover and substantially coextensive therewith in length forming an annular space between said needle cover and said barrel, received in said opening of said needle cover a medicament vial, said medicament vial having an open end and a closed end, received in the open end of the medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper having thereon a threaded projection, said opening in said needle cover being provided with complementary threads adapted to be made up with the threads on said projection to form an interlock between said needle cover and said stopper, said stopper being adapted to be punctured by said needle when said vial is moved into said annular space over said tubular cover to permit the transfer, by reciprocation of said stopper within said vial, of the contents of said medicament vial to the medicament container associated with said barrel and vice versa, said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured.

5. A novel two-compartment device for the administration of medicaments which is particularly adapted for containing a dry or lyophylized product and the diluent therefor in separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed which comprises: a hypodermic syringe barrel having an open end and a closed end, a needle extending from the closed end of said barrel, means for enclosing medicament associated with the open end of said barrel, a tubular needle cover enclosing said needle, one end of said needle cover forming a seal with said syringe, the other end of said needle cover having an opening therein coaxial with said needle, received in said opening a medicament vial, said medicament vial having an open end and a closed ,vial, received in the open end of the medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper being adapted to be punctured by said needle when said vial is moved relative to said tubular needle cover to permit the transfer, by reciprocation of said stopper within said vial, of the contents of said medicament vial to the medicament container associated with said barrel and vice versa, the end of said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured.

6. A novel two-compartment device for the administration of medicaments which is particularly adapted for containing a dry or lyophylized product and the diluent thereforin separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed which comprises: a hypodermic syringe barrel having an open end and a closed end, a boss" extending from said closed end, a needle affixed to said boss, a first medicament vial connected tothe open end of said barrel, a resilient piston stopper in the open end of said vial, the connection between said vial and said barrel being provided by complementary threads on said stopper and said barrel, said barrel acting as a stop to prevent further substantial movement by said stopper relative to the barrel after said stopper has been punctured by the needle, a tubular needle cover enclosing said needle, one end of said needle cover sealing on said boss, the other end of said needle cover having an opening therein coaxial with said needle, received in said opening a second medicament vial, said second medicament vial having an open end and a closed end, received in the open end of said medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper being adapted to be punctured by said needle when said second vial is moved over said tubular needle cover to permit the transfer, by reciprocation of said stopper within said vial, of the contents of said second medicament via] to the first medicament vial and vice versa, said needle cover actingas a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper-has been punctured.

7. A novel two-compartment device for the administration of medicam'ents which is particularly adapted for containing a dry or lyophylized product and the diluent therefor in separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed which comprises: a hypodermic syringe barrel having an open end and a closed end, a boss extending from said closed end, a needle affixed to said boss, a first medicament vial connectedto the open end of said barre], a resilient piston stopper in the open end of said vial, the connection between said vial and said barrel being provided by complementary threads on said stopper and said barrel, said barrel acting as a stop to prevent further substantial movement by said stopper relative to the barrel after said stopper has been punctured by the needle, connected to said barrel in proximity to its closed end, an exterior barrel surrounding said syringe barrel and substantially coextensive therewith in length forming an annular space between said barrels, a tubular needle cover enclosing said needle, one end of said needle cover sealing on said boss, the other end of said needle cover having an opening therein coaxial with said needle, received in said opening a second medicament vial, said second medicament vial having an open end and a closed end, received in the open end of said medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper being adapted to be punctured by said needle when said second vial is moved over said tubular needle cover to permit the transfer, by reciprocation of said stopper within said vial,

.of the contents of said second medicament via] to the first medicament vial and vice versa, said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured.

8. A novel two-compartment device for the administration of medicaments which is particularly adapted for containing a dry or lyophylized product and the diluent therefor in separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed which comprises: a hypodermic syringe barrel having an open end and a closed end, a needle extending from the closed end of said barrel, a plunger in the open end of said barrel for reciprocation therein and forming a seal with the walls of said barrel, a tubular needle cover enclosing said needle, one end ofsaid needle cover forming a seal with said syr inge, the other end of said needle cover having an opening therein coaxial with said needle, received in said opening a medicament vial, said medicament vial having an open end and a closed end, received in the open end of the medicament vial a resilient imperforate piston stopper adapted to reciprocate within said vial, said stopper being adapted to be punctured by said needle when said vial is moved over said tubular cover to permit the transfer, by reciprocation of said stopper within said vial, of the contents of said-medicament vial to the medicament container formed by the interior of said syringe barrel and said plunger, and vice versa, said needle cover acting as a stop to prevent further substantial movement by said stopper relative to the tubular needle cover after said stopper has been punctured. 

